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Can Acute Photobiomodulation Improve Balance and Cognition in Individuals With Ataxia: a Pilot Feasibility Placebo Randomized Controlled Trial.

Can Acute Photobiomodulation Improve Balance and Cognition in Individuals With Ataxia: a Pilot Feasibility Placebo Randomized Controlled Trial.

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07296068
Enrollment
20
Registered
2025-12-22
Start date
2026-06-01
Completion date
2027-12-10
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ataxia

Brief summary

Cerebellar ataxias cause progressive impairments in balance, gait coordination, motor timing, and cognitive functions such as attention and executive control (Buckner, 2013; Salmi et al., 2010; Timmann & Daum, 2007). These symptoms substantially reduce independence and quality of life, and current treatments remain limited. There is an urgent need for safe, low-burden interventions that can support everyday functioning and potentially enhance compensatory neural processes. Transcranial photobiomodulation (tPBM) uses red and near-infrared light (600-1100 nm) to modulate mitochondrial cytochrome-c oxidase, increasing ATP production, reducing oxidative stress, and improving cerebral blood flow (Hamblin, 2016; Salehpour et al., 2019). Several studies show that tPBM can acutely improve cognitive performance and motor control in both healthy adults and clinical groups (Barrett & Gonzalez-Lima, 2013; Chan et al., 2019; Henderson & Morries, 2017). A growing neurobiological literature suggests that light can penetrate posterior cortical areas sufficiently to modulate networks involving cerebellar-cortical loops (Jagdeo et al., 2012). Importantly for ataxia, preliminary work shows that tPBM may acutely improve balance stability and gait metrics in older adults and patients with neurological conditions (Moro et al., 2022; Shin et al., 2021). In our own laboratory, we have observed immediate improvements in sway range and cognitive control in older adults after a 24-minute tPBM session applied over midline and posterior scalp regions. These medium to large size effects are consistent with enhanced sensorimotor integration and improved control of attention in distracting environments. Given that individuals with cerebellar ataxia experience both motor incoordination and difficulties in maintaining cognitive stability under distracting conditions, tPBM is a promising non-pharmacological intervention worth preliminary investigation.

Interventions

DEVICEPhotobiomodulation

Photobiomodulation

The sham device will follow the same protocol but without active light emission.

Sponsors

University of Central Lancashire
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-70 years (inclusive) * Diagnosis of ataxia * Able to walk independently for at least 5 minutes, with or without an assistive device * Able to stand safely for balance testing, with or without an assistive device * Hemodynamically stable (stable blood pressure and heart rate at rest) * On a stable medication regimen for ≥4 weeks prior to enrolment * Sufficient vision and hearing (with usual aids if required) to complete balance and cognitive assessments * Able to complete study questionnaires and cognitive tasks (with assistance for reading/writing if required) * Able and willing to provide written informed consent

Exclusion criteria

* Current or past history of head injury * Use of medications acting on the central nervous system * Active skin conditions on the forehead or scalp * Any other major neurological disorder that could independently affect balance or cognition * Ongoing brain stimulation therapy * History of migraines * Sensitive skin, allergies

Design outcomes

Primary

MeasureTime frameDescription
n-1-back (deviation)BaselineThe n-1-back (deviation) task is a working memory test where participants respond when the current stimulus differs from the one presented n-1 trials earlier.

Secondary

MeasureTime frameDescription
n-1-back (post-deviation)BaselineThe n-1-back (post-deviation) task assesses working memory performance on the trial immediately following a deviation from the stimulus presented n-1 trials earlier.
n-2-back (post-deviation)BaselineThe n-2-back (post-deviation) task assesses working memory performance on the trial immediately following a deviation from the stimulus presented n-2 trials earlier.
n-1-back (post-target)BaselineThe n-1-back (post-target) task assesses working memory performance on the trial immediately following a target that matched the stimulus presented n-1 trials earlier.
n-2-back (post-target)BaselineThe n-2-back (post-target) task assesses working memory performance on the trial immediately following a target that matched the stimulus presented n-2 trials earlier.
n-1-back (load)BaselineThe n-1-back (load) condition measures working memory performance under the cognitive demand of tracking stimuli 1 trial back.
n-2-back (post-load)BaselineThe n-2-back (post-load) condition assesses working memory performance on the trial immediately following a high cognitive load in the n-2-back task.
Coop-Wonka chartBaselineThe Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.
Beck Depression InventoryBaselinePsychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.
n-2-back (deviation)BaselineThe n-2-back (deviation) task is a working memory test where participants respond when the current stimulus differs from the one presented n-2 trials earlier.
State Trait Anxiety InventoryBaselineThe state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.
Insomnia Severity IndexBaselineThe Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.
Epworth Sleepiness ScaleBaselineThe Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.
Everyday Memory Errors QuestionnaireBaselineThe Everyday Memory Errors Questionnaire is a brief self-report instrument designed to assess the frequency of memory lapses in daily life. It consists of multiple items that yield a total score reflecting the extent of everyday memory difficulties.
Falls EfficacyBaselineThe Falls Efficacy Scale is a brief self-report instrument designed to assess confidence in performing daily activities without falling. It consists of multiple items that yield a total score reflecting fear of falling and perceived fall-related self-efficacy.
Anterior-posterior balanceBaselineThe maximum anterior-posterior displacement of the centre of pressure during a two-minute balance task.
Medio-lateral balanceBaselineThe maximum medio-lateral displacement of the centre of pressure during a two-minute balance task.
Pittsburgh Sleep Quality IndexBaselineThe Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.

Countries

United Kingdom

Contacts

Primary ContactJonathan J Sinclair, DSc
jksinclair@lancashire.ac.uk+44787565153

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026